510(k) clearances

Premarket notifications cleared by FDA, newest decision first.

Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.

Data as of 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.

Show the numbers

510(k) clearances by decision year, the last 15 years of ingested records
Year	Clearances
2012	3,135
2013	3,052
2014	3,202
2015	3,020
2016	2,956
2017	3,200
2018	3,062
2019	2,918
2020	2,923
2021	3,023
2022	3,209
2023	3,346
2024	3,129
2025	3,225
2026	2,669

176,466 records, page 878 of 3530

510(k) clearances, page 878 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K121479	Aim	Inneroptic Technology, Inc.	IYO	Class II	2012-09-13
K121335	G-Derm Powder-Free Synthetic Surgical Glove	Hutchinson Sante S.N.C.	KGO	Class I	2012-09-13
K121078	Van Gogh Anterior Cervical Plate System	Accel Spine	KWQ	Class II	2012-09-13
K120737	Tria Laser Hair Removal System	Tria Beauty, Inc.	GEX	Class II	2012-09-13
K113841	Immunocap Allergen Components Bundle	Phadia AB	DHB	Class II	2012-09-13
K113725	Virtuost	O.N. Diagnostics, LLC	KGI	Class II	2012-09-13
K112741	Powder Free Vinyl Patient Examination Glove	Lifestyle Safty Products (Hui Zhou) Co., Ltd.	LYZ	Class I	2012-09-13
K111377	Sterrad(r) 100Nx Sterilizer Duo Cycle	Advanced Sterilization Products	MLR	Class II	2012-09-13
K111128	Labonacheck A1c	Ceragem International, Inc.	LCP	Class II	2012-09-13
K122569	Lava Ultimate Cad/cam Restorative for Cerec Lava Ultimate Cad/cam Restorative for E4d Lava Ultimate Implant Crown Restor	3M Company	EBF	Class II	2012-09-12
K122427	Cs Orthodontic Imaging Software Cs Oms Imaging Software	Carestream Dental LLC	LLZ	Class II	2012-09-12
K122260	Aycan Mobile	Aycan Digitalsysteme GmbH	LLZ	Class II	2012-09-12
K121256	Alco-Screen 02	Chematics, Inc.	DIC	Class II	2012-09-12
K121112	Stryker Video Ureteroscope	Stryker Corp.	FGB	Class II	2012-09-12
K120384	Protector, Injector, Connector	BD Medical-Medical Surgical Systems	LHI	Class II	2012-09-12
K120277	Vital Cough	Lung Assist, Inc.	NHJ	Class II	2012-09-12
K112693	Non-Sterile, Power Free Yellow Latex Examination Gloves	Sgmp Co., Ltd.	LYY	Class I	2012-09-12
K122515	C2-9-D Ultrasound Transducer	GE Healthcare	ITX	Class II	2012-09-11
K122471	Somatom Definition	Siemens Medical Solutions USA, Inc.	JAK	Class II	2012-09-11
K122462	Roth Net Retriever	United States Endoscopy Group, Inc.	FDI	Class II	2012-09-11
K122387	Voluson P6, Voluson P8	GE Healthcare	IYN	Class II	2012-09-11
K122352	Nuvasive Precept Spinal System	NuVasive Inc	NKB	Class II	2012-09-11
K121801	Quintex Cervical Plating System	Aesculap Inc	KWQ	Class II	2012-09-11
K121630	Range Spinal System	K2M, Inc	OSH	Class II	2012-09-11
K121528	Power-Free Nitrile Examination Gloves, Peppermint Scented, Blue Color	Shen Wei (USA), Inc.	LZA	Class I	2012-09-11
K121492	Unicel Dxc Synchron Systems Hemoglobin Alc-(Hba1c-) Reagent	Siemens Healthcare Diagnostics Inc.	LCP	Class II	2012-09-11
K120776	Abutment for Competitive Implant Nobel Active Connection	ZimVie US Corp LLC	NHA	Class II	2012-09-11
K120766	Endoscopic Diagnostic & Treatment System (Modification)	Prosurg, Inc	FAJ	Class II	2012-09-11
K120012	Integra Jarit Video Assisted Thoracic Surgery Instruments	Integra LifeSciences Corporation	GCJ	Class II	2012-09-11
K120009	Testosterone Test System; Calibrator; and Quality Control Material (Assayed and Unassayed)	Abbott Medical	CDZ	Class I	2012-09-11
K113393	Powder Free Black Nitrile Examination Gloves	TG Medical Sdn Bhd	LZA	Class I	2012-09-11
K112223	Euroimmun Anti-Lkm-1 Elisa(lgg)	Euroimmun US Inc.	NBS	Class II	2012-09-11
K112221	Euroimmun Anti-Sla/lp Elisa(lgg)	Euroimmun US Inc.	NIY	Class II	2012-09-11
K122612	Hemashield Woven Double Velour Vascular Graft Model M00202175xxxxx; M00202166xxxxx	Maquet Cardiovascular LLC	MAL	Class II	2012-09-10
K122498	Myosure Xl Tissue Removal Device (1 Pack) Myosure Xl Tissue Removal Device (3 Pack)	Hologic, Inc.	HIH	Class II	2012-09-10
K122363	Non-Sterile, Powder Free Nitrile Examination Gloves, Blue	Siam Sempermed Corp., Ltd.	LZA	Class I	2012-09-10
K121947	Ets Blue Powder-Free Patient Nitrile Examination Gloves	Northstar Healthcare Holdings	LZA	Class I	2012-09-10
K121935	Taperset Hip Small Stems	Consensus Orthopedics, Inc.	LPH	Class II	2012-09-10
K121885	Earlysense Central Display System	Earlysense, Ltd.	MSX	Class II	2012-09-10
K121822	Delicot	American Surgical Company, LLC	HBA	Class II	2012-09-10
K121573	Integra Camino Icp Monitor	Intrgra Lifesciences Corporation	GWM	Class II	2012-09-10
K121372	Fully Automatic Electronic Blood Pressure Monitor	Andon Health Co., Ltd	DXN	Class II	2012-09-10
K121316	Lanx Spinal Fization System	Lanx, Inc.	NKB	Class II	2012-09-10
K121273	Visions Pv .035 Ditital Ivus Catheter	Volcano Corporation	OBJ	Class II	2012-09-10
K120924	Bencox Mirabo Cup Bencox Mirabo Insert (Standard& Elevated Tyes) Bencox Mirabo Cup Screw Hole Plug	Corentec Co., Ltd.	LPH	Class II	2012-09-10
K120126	Barosense Endogastric Tube and Introducer Bougie	Barosense, Inc.	FED	Class II	2012-09-10
K113731	Esensor Respiratory Viral Panel	Clinical Micro Sensors, Inc.	JJH	Class I	2012-09-10
K113060	Unity Toatal Knee System	Corin USA	JWH	Class II	2012-09-10
K112624	Elecsys He4, Elecsys He4 Calset, Elecsys Precicontrol He4, Elecsys He4 Calcheck 5	Roche Diagnostics GmbH	OIU	Class II	2012-09-10
K122301	Guardian II Hemostasis Valve Guardian II Nc Hemostasis Valve	Vascular Solutions Zerusa, Ltd.	DTL	Class II	2012-09-07